Extended Azithromycin Treatment in Prelabor Rupture of Membranes
2 de septiembre de 2026 actualizado por: Alexa Henderson
Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study
The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.
Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.
Participants will:
- Be randomly assigned to one of two groups:
- The standard antibiotic treatment
- The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.
- Participants will be asked to complete a survey regarding their experience and side effects.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Multiple randomized trials have shown that antibiotic treatment for preterm prelabor rupture of membranes (PPROM) increases pregnancy latency and decreases maternal and neonatal morbidity. However, the optimal dosing schedule for azithromycin in PPROM is not fully understood. This pilot study will assess the feasibility of a non-blinded, randomized-controlled trial comparing maternal and neonatal outcomes between the standard PPROM antibiotic regimen and the standard regimen with extended azithromycin therapy in participants with periviable and extremely preterm PPROM between 22- and 28-weeks gestational age. Preliminary data on pregnancy latency, maternal morbidity, and neonatal outcomes will also be collected. Findings from this feasibility study will inform the design of a future, powered study.
The investigators hypothesize that extended azithromycin therapy may be associated with longer pregnancy latency and decreased rates of maternal and neonatal morbidity compared to standard therapy. This hypothesis is exploratory, and the present feasibility study is not powered to test a hypothesis.
The primary objective is to evaluate the feasibility of conducting a non-blinded, randomized controlled trial of extended azithromycin therapy in participants with periviable and extremely preterm prelabor rupture of membranes (PPROM) who desire expectant management between 22 and 28 weeks gestational age. Specifically, we aim to assess feasibility metrics including recruitment and consent rates, randomization procedures, adherence to the study protocol, and completeness of follow-up.
The secondary objectives of this pilot study are to estimate the variability (standard deviation) of pregnancy latency in this population to inform sample-size calculations for a future definitive trial. The investigators will also collect preliminary data on maternal outcomes (e.g., rates of intra-amniotic infection, endometritis, and placental abruption) and neonatal outcomes (gestational age at delivery, NICU admission, morbidity) for planning purposes. Additionally, the investigators will review placental pathology reports to identify the stage/grade of chorioamnionitis per the Amsterdam criteria. The investigators will obtain an initial estimate of the effect of extended azithromycin on pregnancy latency, recognizing that this pilot study is not powered to detect clinically meaningful differences.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Alexa Henderson, MD
- Número de teléfono: 9136019107
- Correo electrónico: hendersona8@upmc.edu
Copia de seguridad de contactos de estudio
- Nombre: Christina Megli, MD, PhD
- Correo electrónico: meglicj@upmc.edu
Ubicaciones de estudio
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15217
- Reclutamiento
- University of Pittsburgh Magee-Womens Hospital
-
Contacto:
- Alexa Henderson, MD
- Número de teléfono: 9136019107
- Correo electrónico: hendersona8@upmc.edu
-
Contacto:
- Christina Megli, MD, PhD
- Correo electrónico: meglicj@upmc.edu
-
Investigador principal:
- Christina Megli, MD, PhD
-
Sub-Investigador:
- Alexa Henderson, MD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Singleton gestation
- Gestational age at time of PPROM between 22w0d and 28w0d
- Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)
- Remain pregnant 48 hours after presentation.
- Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included.
- Pregnant patients below the age of 18 are eligible.
Exclusion Criteria:
- Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)
- Lethal congenital defects
- Multiple gestation
- Ongoing alternative antibiotic treatment
- Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic
- History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
- Known prolongation of QT interval
- History of torsades de pointes
- Congenital long QT syndrome
- Bradyarrhythmia
- Decompensated heart failure
- Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents
- Impaired hepatic function
- GFR<10 mL/min
- Diagnosis of myasthenia gravis
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Standard Antibiotic Regimen
A single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days.
|
Oral Azithromycin 1g once.
|
|
Experimental: Extended Azithromycin Regimen
The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.
|
Oral Azithromycin 1g once.
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recruitment Capability
Periodo de tiempo: From recruitment to enrollment, up to 3 days.
|
Number of participants recruited per week/month
|
From recruitment to enrollment, up to 3 days.
|
|
Participant Eligibility
Periodo de tiempo: From recruitment until enrollment, up to 3 days.
|
Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility
|
From recruitment until enrollment, up to 3 days.
|
|
Retention and Dropout Rates
Periodo de tiempo: From recruitment to completion of the study, up to 4 months.
|
Percentage of patients who complete study and reasons for withdrawal from study.
|
From recruitment to completion of the study, up to 4 months.
|
|
Intervention Delivery
Periodo de tiempo: From recruitment to completion of intervention, up to 15 days.
|
Percentage of interventions delivered as intended
|
From recruitment to completion of intervention, up to 15 days.
|
|
Participant Acceptability
Periodo de tiempo: At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
|
Likert-scale survey evaluating the participant's perceived affective attitude, burden, ethicality, intervention coherence, confidence, opportunity costs, general acceptability, and side effects related to the study.
|
At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
|
|
Data Collection Procedures
Periodo de tiempo: From recruitment to completion of postpartum period, up to 6 months.
|
Data completeness measured as number of participants with complete data entry.
|
From recruitment to completion of postpartum period, up to 6 months.
|
|
Resource Use and Cost
Periodo de tiempo: From recruitment to postpartum period, up to 6 months.
|
Total cost versus planned budget, time and staffing required.
|
From recruitment to postpartum period, up to 6 months.
|
|
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Periodo de tiempo: Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
|
Adverse events associated with antibiotic usage, maternal and neonatal outcomes, bacterial resistance profiles.
Assessed using previously validated Medication Side Effect survey.
|
Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
|
|
Protocol Deviations
Periodo de tiempo: From recruitment to completion of intervention, up to 15 days.
|
Incidence of protocol deviation, indications for protocol deviation.
|
From recruitment to completion of intervention, up to 15 days.
|
|
Time for Delivery
Periodo de tiempo: From recruitment to completion of postpartum period, up to 6 months.
|
Amount of study team time needed for delivery.
|
From recruitment to completion of postpartum period, up to 6 months.
|
|
Financial Resources
Periodo de tiempo: From recruitment to postpartum period, up to 6 months.
|
Amount of monetary resources needed for study delivery.
|
From recruitment to postpartum period, up to 6 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pregnancy Latency
Periodo de tiempo: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
|
Number of days participants remain pregnant after PPROM until delivery
|
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
|
|
Pregnancy Outcome
Periodo de tiempo: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
|
Intrauterine fetal demise, neonatal demise while in NICU, living infant to NICU discharge.
|
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
|
|
NICU Admission
Periodo de tiempo: From day of delivery through neonatal discharge, up to 4 months.
|
Requirement for NICU admission.
|
From day of delivery through neonatal discharge, up to 4 months.
|
|
Neonatal Ventilatory Support
Periodo de tiempo: From day of delivery through neonatal discharge, up to 4 months.
|
Level of ventilatory support required for neonate (none, bubble CPAP, intubation).
|
From day of delivery through neonatal discharge, up to 4 months.
|
|
Neonatal Sepsis
Periodo de tiempo: From day of delivery through neonatal discharge, up to 4 months.
|
Rates of early-onset sepsis, late-onset sepsis (including culture positive sepsis and culture-negative, clinically suspected sepsis)
|
From day of delivery through neonatal discharge, up to 4 months.
|
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Neonatal Intraventricular Hemorrhage (IVH)
Periodo de tiempo: From day of delivery through neonatal discharge, up to 4 months.
|
Grade of IVH if present.
|
From day of delivery through neonatal discharge, up to 4 months.
|
|
Neonatal respiratory distress syndrome
Periodo de tiempo: From day of delivery through neonatal discharge, up to 4 months.
|
Documented respiratory distress syndrome by neonatology providers.
|
From day of delivery through neonatal discharge, up to 4 months.
|
|
Necrotizing enterocolitis
Periodo de tiempo: From day of delivery through neonatal discharge, up to 4 months.
|
Rate of documented necrotizing enterocolitis by neonatology team.
|
From day of delivery through neonatal discharge, up to 4 months.
|
|
Mode of delivery
Periodo de tiempo: From day of PPROM (D0) through day of delivery, up to 3 months.
|
Cesarean section, vaginal delivery, or operative delivery.
|
From day of PPROM (D0) through day of delivery, up to 3 months.
|
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Indication for delivery
Periodo de tiempo: From day of PPROM (D0) through day of delivery, up to 3 months.
|
Non-reassuring fetal status, labor, intra-uterine infection, placental abruption, cord prolapse.
|
From day of PPROM (D0) through day of delivery, up to 3 months.
|
|
Maternal group B streptococcus status
Periodo de tiempo: From day of PPROM (D0) through day of delivery, up to 3 months.
|
Positive or negative group B streptococcus maternal rectovaginal culture.
|
From day of PPROM (D0) through day of delivery, up to 3 months.
|
|
Maternal postpartum hemorrhage
Periodo de tiempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
Estimated blood loss greater than 1000mL after delivery.
|
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
|
Suspected intraamniotic infection
Periodo de tiempo: From day of PPROM (D0) through day of delivery, up to 3 months.
|
Defined as maternal temperature greater than 39 degrees Celsius OR maternal temperature between 38.0-38.9
degrees Celsius plus one or more additional clinical risk factors: maternal leukocytosis greater than 15,000/mm^3, purulent cervical drainage, or fetal tachycardia.
|
From day of PPROM (D0) through day of delivery, up to 3 months.
|
|
Confirmed intraamniotic infection
Periodo de tiempo: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
|
Positive amniotic fluid test result OR placental pathology demonstrating histologic evidence of infection or inflammation.
|
From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
|
|
Maternal sepsis
Periodo de tiempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
Suspected sepsis documented by clinical provider in chart or culture proven sepsis.
|
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
|
Maternal placental abruption
Periodo de tiempo: From day of PPROM (D0) through day of delivery, up to 3 months.
|
Clinical evidence of placental abruption documented by OBGYN provider.
|
From day of PPROM (D0) through day of delivery, up to 3 months.
|
|
Maternal ICU Admission
Periodo de tiempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
Required admission to adult ICU prior to or after delivery.
|
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
|
Maternal postpartum endomtritis
Periodo de tiempo: From day of delivery through 6 weeks postpartum.
|
Documented clinical diagnosis of endometritis in participant chart.
|
From day of delivery through 6 weeks postpartum.
|
|
Maternal retained products of conception
Periodo de tiempo: From day of delivery through 6 weeks postpartum.
|
Clinical documentation of retained products of conception in participant chart.
|
From day of delivery through 6 weeks postpartum.
|
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Additional maternal surgical procedures
Periodo de tiempo: From day of delivery through 6 weeks postpartum.
|
Requirement of additional surgical procedures following delivery (suction dilation and curettage, hysterectomy).
|
From day of delivery through 6 weeks postpartum.
|
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Maternal blood transfusion
Periodo de tiempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
Documented maternal blood transfusion following delivery.
|
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
|
Maternal antibiotic course completion
Periodo de tiempo: From day of PPROM (D0) through day of delivery, up to D14.
|
Number of participants in intervention arm who completed the extended antibiotic course.
|
From day of PPROM (D0) through day of delivery, up to D14.
|
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Additional maternal antibiotic administration
Periodo de tiempo: From day of PPROM (D0) through day of delivery, up to 3 months.
|
Maternal antibiotics administered for other indications after enrollment in the study.
|
From day of PPROM (D0) through day of delivery, up to 3 months.
|
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Maternal placental pathology
Periodo de tiempo: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
|
Maternal and fetal inflammation stage/grade as defined by the Amsterdam Criteria.
|
From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Christina Megli, MD/PhD, University of Pittsburgh Magee-Womens Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de agosto de 2026
Finalización primaria (Estimado)
1 de mayo de 2028
Finalización del estudio (Estimado)
1 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY25110085
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All IPD collected throughout the study will potentially be shared with future collaborating sites if the feasibility trial is expanded to a multi-center trial.
Marco de tiempo para compartir IPD
Beginning 3 months after publication without end.
Criterios de acceso compartido de IPD
Collaborating principal investigators will have access to IPD.
The information will be shared upon request via secure email or to advance further research efforts in the case of a multi-site trial.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .